Quality Engineer

Fusion Life Sciences technologies LLC; Marlborough (MA); On-site; USD 55,000 - 62,000; Full time

Job summary

Fusion Life Sciences Technologies LLC seeks a Quality Engineer for a 6-month contract in Marlborough, MA. You will own deviations, perform RCA, and drive CAPA through closure while collaborating across Manufacturing, Quality, Engineering, Validation, and Operations.

The role requires 5+ years in the medical-device space with strong knowledge of FDA requirements and QMS. Hands-on problem-solving, documentation, and cross-functional teamwork are essential as you support remediation efforts.

Qualifications

• Bachelor's degree in Engineering, Quality, Manufacturing Engineering, Mechanical Engineering, or a related technical field.
• 5+ years of experience in the medical-device industry with FDA remediation exposure.
• Hands-on RCA, deviation investigations, CAPA, NCRs, change control, risk assessment, and process improvement.
• Strong knowledge of FDA medical-device requirements and QMS.
• Experience collaborating with cross-functional Manufacturing, Quality, Engineering, and Operations teams.
• Solid documentation and problem-solving skills for investigating complex issues.

Responsibilities

• Support FDA remediation activities related to manufacturing and quality processes.
• Investigate manufacturing deviations, nonconformances, and quality issues.
• Perform detailed root cause analysis and identify systemic causes.
• Develop, implement, and track CAPA activities through closure.
• Partner with Manufacturing, Quality, Engineering, Validation, and Operations teams to implement corrective actions.
• Support process improvements, process validation, equipment qualification, and manufacturing-readiness activities.
• Review and update manufacturing procedures, work instructions, specifications, and technical documentation.
• Analyze quality and manufacturing data to identify trends, recurring issues, and risks.
• Support audit and regulatory inspection readiness.

Skills

Root cause analysis

CAPA

Deviation investigations

Change control

Risk assessment

Process improvement

Quality systems (FDA 21 CFR Part 820)

Cross-functional collaboration

Documentation

Education

Bachelor's degree in Engineering or related field

Tools

FDA remediation

Job description

Updated October 1, 2026

At a glance
Company: Fusion Life Sciences Technologies LLC
Location: Marlborough, MA 01752
Pay: $40 – $45 per hour
Job Type: Contract (6 months)
Experience: 5+ years

Why this job is worth considering

This Quality Engineer opening supports FDA remediation work inside a regulated medical-device manufacturing environment in Marlborough, MA. You'd investigate deviations and nonconformances, run root cause analysis, and own CAPA activities through closure, while partnering across Manufacturing, Quality, Engineering, Validation, and Operations to implement corrective actions. The role also touches process improvement, process validation, equipment qualification, and audit and regulatory-inspection readiness. It's a strong fit if you want hands-on ownership of root cause and CAPA work rather than a purely administrative quality role. This is a 6-month contract paying $40–$45 per hour, with a 5+ year baseline and a real preference for candidates with 10+ years in regulated manufacturing.

What you'll be doing

• Support FDA remediation activities related to manufacturing and quality processes.
• Investigate manufacturing deviations, nonconformances, and quality issues.
• Perform detailed root cause analysis (RCA) and identify systemic and contributing causes.
• Develop, implement, and track CAPA activities through successful closure.
• Partner with Manufacturing, Quality, Engineering, Validation, and Operations teams to implement corrective actions.
• Support process improvements, process validation, equipment qualification, and manufacturing-readiness activities as applicable.
• Review and update manufacturing procedures, work instructions, specifications, and technical documentation.
• Analyze quality and manufacturing data to identify trends, recurring issues, and potential risks.
• Support audit and regulatory inspection readiness.

What we're looking for

Required

• Bachelor's degree in Engineering, Quality, Manufacturing Engineering, Mechanical Engineering, or a related technical field.
• 5+ years of experience, with strong exposure to the medical-device industry and FDA remediation activities.
• Hands-on experience with root cause analysis, deviation investigations, CAPA, nonconformances/NCRs, corrective and preventive actions, change control, risk assessment, and process improvement.
• Strong understanding of FDA medical-device requirements and quality management systems.
• Experience working with cross-functional Manufacturing, Quality, Engineering, and Operations teams.
• Strong technical documentation and problem-solving skills, with the ability to independently investigate complex manufacturing and quality issues.

Preferred

• 10+ years of experience in Manufacturing Engineering, Quality Engineering, or related regulated manufacturing functions.
• Experience with FDA 483, Warning Letter, audit findings, or remediation programs.
• Experience with FDA 21 CFR Part 820/QMSR and ISO 13485.
• Experience with process validation and equipment qualification.
• Experience in sterile/aseptic or controlled manufacturing environments.
• Lean/Six Sigma experience or certification.
• Experience supporting regulatory inspections and quality-system remediation.

Pay, benefits and schedule

$40–$45 per hour, on a 6-month contract.

About Fusion Life Sciences Technologies LLC and apply

Fusion Life Sciences Technologies LLC is a staffing and workforce-solutions firm placing engineers and technical professionals with regulated life sciences, medical device, and pharmaceutical companies, with clients worldwide. Placements are made on a W2 basis, not as 1099 contractors, and Fusion's work spans manufacturing process setup, quality and compliance, regulatory affairs, and FDA remediation governed by frameworks like 21 CFR Part 820, ISO, GAMP, and USP. This Quality Engineer role is a client placement supporting FDA remediation work at a regulated medical-device manufacturing site.